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STVHCS Research and Development. Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service. What is Considered VA Research?. Definition of VA Research. Research sponsored by the VA

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stvhcs research and development

STVHCS Research and Development

Kimberly Summers, PharmD

Assistant Chief for Clinical Research

South Texas Veterans Health Care System

Research & Development Service

definition of va research
Definition of VA Research
  • Research sponsored by the VA
  • Research conducted using any property or facility of STVHCS
  • Research conducted by or under the direction of any salaried or without compensation (WOC) employee of the STVHCS during and in connection with her/his STVHCS responsibilities
  • Funds for the research activities are managed by the STVHCS or Biomedical Research Foundation of South Texas
  • Research which recruits subjects at the STVHCS or uses the STVHCS's nonpublic information to identify or contact human research subjects for research purposes
r d approval
R&D Approval
  • Must have R&D approval letter prior to any of the following being conducted at the VA
    • Recruitment
    • Obtaining informed consent
      • Having an IRB approved VA consent form does NOT constitute R&D approval
    • Enrollment
    • Providing patient follow up
    • Accessing CPRS for research purposes
  • An IRB approval letter does NOT constitute R&D approval
research privileges
Research Privileges
  • Research credentialing and privileges are required prior to work on any VA protocol
  • Requirements are different for the following groups
    • VA Employees
      • Investigators and study personnel
    • Fellows, Residents, and Students
    • Non-VA investigators or study personnel
    • Exempt study staff
va research privileges
VA Research Privileges
  • VA Appointment
    • VA employee or WOC status with research privileges or Trainee
    • All mandatory training courses
    • Signed Intellectual Property Agreement (IPA)- WOCs, Trainees, Contract credentialed providers
    • Signed Written Release of Information- WOCs only
    • Copy of Appointment Memo- Trainees
    • Medical Staff Member Appointment Request signed by appropriate Service Chief- Contract credentialed providers
  • Documentation of Human Subjects Training
  • Conflict of Interest Form
    • Required for all investigators and study personnel
  • Scope of practice
    • Required for all investigators and study personnel EXCEPT credentialed medical staff providers
    • Signed by principal investigator(s) and/or supervising physician
exempt personnel
Exempt Personnel
  • Study personnel who are not physically conducting research on VA property, only have access to de-identified data and/or not directly working with research subjects
    • Examples: lab personnel, data or administrative personnel
  • Requirements
    • Information Security 201 for Research and Development Personnel
      • LMS account created
    • Memorandum from PI denoting what their role in the study will be 
    • Conflict of Interest Form        
conflict of interest form
Conflict of Interest Form

No longer protocol specific

Required for all investigators and collaborators

Collaborators = all research personnel

New form will be collected as part of

New personnel application

New protocol submission if old version of form is on file

Must be verified as accurate or updated annually

Verified by the PI at continuing review

New protocol submission if investigator or personnel have not been engaged in research for greater than one year

r d submission date
R&D Submission Date
  • The first Monday of each month
  • New Requirement
    • One of the followingmust have occurred prior to application submission to the R&D office
      • IRB final resubmission for full IRB Board 1 or IRB 3 research protocols
      • IRB administrative review for IRB expedited or exempt research
      • Final IRB approval
r d administrative review appointments
R&D Administrative Review Appointments
  • New Requirement
    • An appointment with the investigator and/or study coordinator is required to address any administrative stipulations
    • The intent of the meeting is to address, correct, and finalize any administrative stipulations in real time to shorten the overall approval time
    • This appointment may be made at the time of application submission or may be scheduled by calling the R&D office at VA ext 16335.
r d administrative stipulations and final approval
R&D Administrative Stipulations and Final Approval
  • New Requirement
    • All administrative stipulations must be addressed at least one week prior to the R&D Committee Meeting for the protocol to be placed on the agenda
    • IRB approval may still be pending at the time of resubmission
  • Final R&D approval can be granted when
    • IRB approval is in place
    • All R&D Committee stipulations have been addressed
slide16
Electronic form available on Research website

Items 1-7. All fields are required. Information entered on page 1 will be auto filled on pages 2 through 6.

Item 8. Complete the applicable table for each VA Service that will be utilized as part of your project.

statement of clinical impact form
Statement of Clinical Impact Form
  • Procedures must be consistent with protocol
  • List ALL procedures beyond routine clinical care
    • Additional, altered process or increased frequency
    • Procedures should be specific
  • Collaborating service will not sign off on statement of clinical impact if information provided is incomplete
routing statement of clinical impact forms
Routing Statement of Clinical Impact Forms
  • Submit completed forms via email to stxresearch@va.gov
  • If you have any questions completing the form
    • Contact Angela Casas in the Research office at VA ext 15523
  • The Research office will forward completed forms to the appropriate VA Services for signatures
  • An electronic signed copy will be provided for your records
  • If project requirements change for any VA Service, a revised form must be submitted to the Research office
va research data security checklist
VA Research Data Security Checklist

Required for ALL submissions

If the research does NOT involve human subjects OR their identifiable information

Only PI signature on front page is required for completion

data security checklist
Data Security Checklist

Documentation for

Types of information collected

Disclosures to third parties

Location of storage

Length of retention

Should be consistent in the

Protocol

Data security checklist

Informed consent document

All sections should state the same information

va sensitive research data
VA-Sensitive Research Data

Individually-identifiable research data collected on a veteran subject through a STVHCS approved protocol

Individually-identifiable research data collected on a veteran or non-veteran within the STVHCS

Individually-identifiable research data collected as part of a VA-funded study

individually identifiable data hipaa identifiers

Individually-identifiable - Data HIPAA Identifiers

1. Names

2. ALL geographic subdivisions smaller than the state

3. All elements of dates smaller than a year and all ages over 89

4. Phone numbers

5. Fax numbers

6. E-mail addresses

7. Social Security numbers (SSN)

8. Medical record number

9. Health plan beneficiary numbers

10. Any other account numbers

11. Certificate/license numbers

12. Vehicle identifiers and license plate numbers

13. Device identifiers and serial numbers

14. WEB URL's

15. Internet IP address numbers

16. Biometric identifiers (fingerprint, voice prints, retina scan, etc)

17. Full face photographs or comparable images

18. Any other unique number, characteristic or code

hipaa identifiers continued
HIPAA Identifiers Continued

Any other unique number, characteristic or code

Scrambled SSN

Initials

Last four digits of SSN

Employee numbers

Etc.

HIPPA also states that the entity does not have actual knowledge that the remaining information could be used alone or in combination with other information to identify an individual who is the subject of the information

hipaa and the common rule
HIPAA and The Common Rule
  • Two different regulations
  • VA requires de-identification by both
  • Common Rule states the identity of the subject can not be readily ascertained by information remaining after removal of all 18 HIPAA identifiers
    • After stripping all 18 identifiers the remaining information may still be identifiable (e.g. through statistical analysis)
not va sensitive data
Not VA-Sensitive Data

Non-identifiable data

Data collected on non-veterans outside of the VA on a non-VA funded project

keys to coding systems
Keys To Coding Systems
  • If non-identifiable information is linked to identifiable information with the use of log (e.g. coding system)
    • Logs are identifiable and VA-sensitive research data
    • Applies to both data and specimen logs
disclosures to non stvhcs entities
Disclosures to Non-STVHCS Entities
  • Temporary access to research subject information, without removal of any data from the facility
    • Examples: external study monitors, auditors, collaborators, etc
  • Access to research subject information because the data will leave the STVHCS facility
    • For identifiable information disclosed outside the STVHCS, you must state how the data will be securely transported
    • Transfer or transmission other than to the sponsor or its designated contract monitor or data center, requires prior written approval by the ACOS/Research, STVHCS Privacy Officer and Information Security Officer
  • The Data Security Checklist, HIPPA authorization, and protocol should all be consistent
accounting of disclosures
Accounting of Disclosures
  • An accounting of disclosures must be kept for all VA sensitive information transferred or transmitted outside the STVHCS
    • Excluding non-identifiable data and limited data sets
    • Limited data sets exclude certain direct identifiers but may contain some identifiable information
      • Examples: city, state, zip code, scrambled SSN, or initials
    • The web-based accounting for Disclosure of VA-sensitive Research Information can be found on the Research and Development Service Webpage: http://www.southtexas.va.gov/research.
storage of va sensitive paper research data
Storage of VA-Sensitive Paper Research Data
  • Lower risk of loss or compromise
  • Physical security controls
    • Within the VA system
      • Locked room, locked cabinet
      • Access limited to research staff
    • At the UTHSCSA
      • Physical security arrangements must be inspected and approved by ACOS/Research and ISO
storage of va sensitive electronic research data
Storage of VA-Sensitive Electronic Research Data

Risk of loss or compromise is high

Must be stored within the VA system (e.g. behind the VA firewall)

VA research server recommended

Accessed directly through the VA network from a VA computer or

Through VPN from a non-VA computer

Encrypted VA computer in VA office

Rare instances

Explain requirement for storage outside the server

continuing review process
Continuing Review Process
  • New form
  • VA specific information in addition to IRB continuing review form
    • Submission of the IRB continuing review form and/or approval letter to the R&D office is NOT required
  • Exempt research
    • VA continuing review form required at least annually
    • Updated protocol abstract required anually
continuing review process33
Continuing Review Process
  • Protocol approval at the STVHCS will expire if
    • Continuing review is not completed
      • Must be approved by IRB AND R&D Committee prior to the expiration date
    • Training requirements for the PI are not up-to-date at the time of continuing review
      • Co-investigators and other study personnel will be removed from active protocols if training requirements are not up-to-date
  • Expiration of approval will be corrected upon receipt and satisfactory review and approval of the required documentation
research record must contain
Research Record Must Contain
  • Copy of the signed and dated consent and initial enrollment progress note
    • Scanning of VA Form 10-1086 (Informed Consent Document)
  • Information on possible drug interactions and adverse effects of investigational drugs being administered
    • Scanning of VA Form 10-9012 (Investigational Drug Information Record)
  • Any research information which has the potential to impact medical care
    • Research progress notes
  • Disenrollment or termination from a study
enrollment consent template research consent enrollment note
Enrollment Consent Template: Research Consent / Enrollment Note
  • Must be entered into the subject’s health record (CPRS) after IC has been obtained
  • Template in CPRS flags patients Medical Record in postings
  • Template contains all the required information for documentation of consent process
  • Template must be used in order to scan IC document
  • Note must indicate if the study involves the use of investigational medications
investigational drug information record va form 10 9012
Investigational Drug Information Record (VA Form 10-9012)
  • Required for
    • Investigational drug for which an IND has been filed
    • Approved drug being studied for unapproved use in a controlled, randomized, or blinded clinical trial
    • Approved drug being studied for approved use in a controlled, randomized, or blinded clinical trial
  • PI must ensure a completed and signed copy is submitted to MR for scanning
  • Pharmacy will not dispense any study medication for a research subject until 10-9012 forms have been scanned
authorized prescribers for investigational medications
Authorized Prescribers for Investigational Medications
  • All prescribers for investigational medications must be listed on VA form 10-9012
    • Should be consistent with FDA 1572
  • Prescribers must be credentialed at the VA to write medication orders
    • Should be consistent with Scope of Practice if applicable
  • VA form 10-9012 must be amended if
    • Prescribing investigators are added to a protocol
    • Principal investigator changes
  • Research Pharmacist verifies orders are received by an investigator listed on the 10-9012
updated consent template research consent update note
Updated Consent Template: Research Consent / Update Note
  • Any changes to the IC resulting in an addendum or updated IC document
    • Must be entered into the subject’s health record (CPRS) after IC has been obtained
    • Template in CPRS flags patients Medical Record in postings
  • All IC addendums and updated IC documents must be scanned in CPRS
research disenrollment termination note
Research Disenrollment Termination Note
  • Must be entered into the subject’s health record (CPRS)
  • Template in CPRS flags patients Medical Record in postings
  • Required information in template
    • Title of Study
    • Date of disenrollment or termination
    • Contact name and number
at the time of the monitoring visit
At The Time Of The Monitoring Visit
  • Study monitor must sign in at the Research Office and receive a visitor badge
    • Check-in at Room Q202.1 or on BRU
    • A Research Monitor Log will be maintained by the Research Office
  • Study monitor will be provided
    • External Monitor Agreement Form
      • Must be reviewed and signed at the time of check in
    • STVHCS Report of Clinical Research Monitoring Visit
      • Must be returned to the Research office
findings that require an exit interview
Findings That Require an Exit Interview
  • Suspicions or concerns that serious non-compliance may exist
  • All findings of serious non-compliance with study protocol, IRB requirements or applicable regulations and policies
  • Monitoring visits conducted by regulatory agencies (FDA, OHRP)
physician referral
Physician Referral
  • Veteran patients may be formally referred from VA staff for a VA-approved research protocol
  • Veteran patients may NOT be formally referred from VA staff to off-site locations for non-VA approved research protocols
    • Veteran patients have a right to seek care from and enroll in research studies outside the VA
    • Informing veteran patients of the availability of an outside research study is not considered a referral, if the referring physician will not have ongoing participation in the care of the patient
informing veterans about off site non va research studies
Informing Veterans About Off-site Non-VA Research Studies
  • Veterans must be informed that VA will not be responsible for any costs related to their care as part of the off-site research
  • Enrollment should occur through the veterans’ own initiative in contacting the study personnel at the off-site institution
  • Provision of information to a veteran regarding off-site research and their associated responsibility for cost should be documented by the VA physician in a progress note in CPRS
  • VA records may not be accessed to obtain information for research purposes of a non-VA off-site study
cprs can be accessed for information on any veteran enrolled in a research protocol
CPRS can be accessed for information on any Veteran enrolled in a research protocol?

YES

For VA approved research

Following signed informed consent by the veteran

As per approved research protocol

NO

For Veterans enrolled in non-VA approved research

Must obtain a signed release of information from the subject and receive copies thru Medical Records

recruitment advertisements posted at the stvhcs
Recruitment Advertisements Posted at the STVHCS
  • Steps required
    • Approved and stamped by UTHSCSA IRB
    • Verification of active protocol and stamped by VA Research Office
    • Posting approval by VA Public Affairs Office
  • Recruitment of VA patients into non-VA studies through posted advertisements in NOT allowed
questions

Questions?

Kimberly Summers, PharmD

Office: (210) 617-5300 ext 15969

Email: kimberlyk.Summers@va.gov